The opportunity
Senior Director, Regulatory Affairs CanadaScarborough, OntarioHybrid
As Senior Director, Regulatory Affairs Canada, you will lead the strategic direction and execution of regulatory activities across Teva Canada’s full pharmaceutical portfolio, including generic, biosimilar and innovative (specialty) products. You will oversee the development and implementation of regulatory strategies for new product submissions, lifecycle management, and market access, ensuring compliance with Health Canada regulations and alignment with global regulatory standards. This role requires strong leadership, cross-functional collaboration, and the ability to influence regulatory outcomes that support both operational excellence and long-term business growth.How you’ll spend your day
Strategic Leadership:
Define and drive regulatory strategies for both generic and innovative submissions, including complex biologics, biosimilars, and specialty products. Ensure alignment with corporate goals and Health Canada requirements.
Team Leadership & Development:
Lead, mentor, and develop a high-performing regulatory team with expertise across product types. Foster a culture of accountability, innovation, and continuous improvement.
Regulatory Oversight:
Oversee the preparation and submission of high-quality regulatory dossiers (e.g., ANDS, NDS, CTA, BLA) and responses to Health Canada. Ensure timely, compliant, and strategic submissions.
Cross-Functional Collaboration:
Partner with Global R&D, Clinical, Medical Affairs, Operations, Quality, and Commercial teams to provide regulatory guidance throughout the product lifecycle.
Compliance & Risk Management:
Monitor regulatory changes and assess their impact on both generics and innovative portfolios. Ensure proactive risk mitigation and compliance with evolving Health Canada guidelines.
All other duties as assigned.
